Satisfaction of Treatment Among Elderly Patients With Insulin Therapy

This study has been completed.

Sponsor:

Emory University

ClinicalTrials.gov Identifier:

NCT01240200

First Posted: November 15, 2010

Last Update Posted: November 5, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

Several studies have shown that high blood sugar (glucose) levels are associated with diseases caused by the diabetes. Controlling the glucose may prevent these complications. As people age, their bodies become unable to make enough insulin to control the blood sugars. Pills used to treat diabetes may help for a while, but many times this does not last. When the blood sugar is too high, insulin is frequently recommended and used to treat diabetes. Insulin is often started by adding a long-acting insulin to the medicines a patient already takes. In this study, glargine insulin will be taken together with the diabetes pills currently being used. Glargine is a long-acting insulin which is given under the skin once a day. Glargine is approved for use in the treatment of patients with diabetes by the FDA (Food and Drug Administration).

Currently, insulin delivery is only available as a shot. The purpose of this study is to compare how satisfied patients are when using two different types of insulin shots. Specifically, this study aims to determine if people over 65 years old are more satisfied taking insulin shots by pens or syringes. Everyone who joins in this study will have a chance to use the insulin syringes and the insulin pens.

The ability of patients to give themselves shots can affect how well the sugar is controlled. As people age, medical and other problems may develop that affect their ability to do certain things. Another aim of this study is to determine if the ability to use an insulin pen and insulin syringe is affected by age or some other problem.

During this 25 week long study, patients will be treated with insulin given by a syringe for 12 weeks and by a pen for 12 weeks. Questionnaires will be given to determine satisfaction with treatment throughout the study. The investigators hypothesize that among elderly patients with type 2 diabetes mellitus failing oral agent therapy, treatment with basal insulin via a pen device results in higher treatment satisfaction scores and more accurate dosing than treatment with basal insulin via conventional vial/syringe methods.

A total of 56 subjects with type 2 diabetes will be recruited into this study. The site for the study is Grady Memorial Hospital clinics.

Further study details as provided by Christopher Newton, Emory University:

Primary Outcome Measures:

Treatment Satisfaction Based on Patient Survey [ Time Frame: at 0 weeks ]

The primary outcome of the study is to determine differences in treatment satisfaction scores in elderly patients with diabetes treated with basal insulin delivered via a pen device versus a syringe.

Treatment Satisfaction [ Time Frame: 12 weeks ]

The treatment satisfaction scores were obtained from the Diabetes Treatment Satisfaction Questionnaire: Status (DTSQs). The questionnaire contains eight items scored on a seven-point scale (0-6). DTSQs scores range from, e.g, 6 = very satisfied to 0 = very dissatisfied. The total satisfaction score when using the DTSQs ranges from 0 to 36; and the total score is obtained from summed scores from questions 1, 4, 5, 6, 7, and 8. This outcome measure is assessed after the first intervention (at 12 weeks into the study).

Treatment Satisfaction [ Time Frame: at 24 weeks ]

The primary outcome of the study is to determine differences in treatment satisfaction scores in elderly patients with diabetes treated with basal insulin delivered via a pen device versus a syringe.

Secondary Outcome Measures:

Blood Glucose Control [ Time Frame: at 0 weeks ]

Secondary outcomes include differences between treatment regimens in any of the following measures:

Percent of subjects with A1c <7.0% without hypoglycemia, A1c and mean fasting blood glucose at the end of each 12 week treatment period and percent with mean fasting glucose <130 mg/dL without hypoglycemia

Blood Glucose Control [ Time Frame: at 0 weeks ]

Secondary outcomes include differences between treatment regimens in any of the following measures:

Number of episodes of nocturnal hypoglycemia, any hypoglycemia, severe hypoglycemia

Accuracy of insulin dosing at weeks 0,12 and 24

Blood Glucose Control [ Time Frame: at 12 weeks ]

Percent of subjects with A1c <7.0% without hypoglycemia, A1c and mean fasting blood glucose at the end of each 12 week treatment period and percent with mean fasting glucose <130 mg/dL without hypoglycemia

Blood Glucose (Low Blood Glucose) [ Time Frame: at 12 weeks ]

Secondary outcomes include differences between treatment regimens in any of the following measures:

Number of episodes of nocturnal hypoglycemia, any hypoglycemia, severe hypoglycemia

Accuracy of insulin dosing at weeks 0,12 and 24

Blood Glucose (Low Blood Glucose) [ Time Frame: at 24 weeks ]

Secondary outcomes include differences between treatment regimens in any of the following measures:

Number of episodes of nocturnal hypoglycemia, any hypoglycemia, severe hypoglycemia

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

65 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Males or females aged ≥65 years

History of type 2 diabetes of >3 months duration

Current use oral antidiabetic agents and/or diet to treat the diabetes

A1c ≤10.0% and fasting glucose ≤300 mg/dL

A1c ≥7.0% and/or fasting glucose ≥150 mg/dL -

Exclusion Criteria:

Subjects with a known allergy to glargine or any of its metabolites

Subjects unwilling to self-inject insulin

Inability to self-monitor blood glucose

Current or previous use of insulin for more than 6 continuous months prior to study enrollment